BD FACSDuet 663128
GUDID 00382906631282
BD FACSDuet Sample Prep US
BECTON, DICKINSON AND COMPANY
Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD| Primary Device ID | 00382906631282 |
| NIH Device Record Key | 2da96adb-a46b-4a9b-a740-8e738b780b09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD FACSDuet |
| Version Model Number | 663128 |
| Catalog Number | 663128 |
| Company DUNS | 024230633 |
| Company Name | BECTON, DICKINSON AND COMPANY |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382906631282 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201814
FDA Product Code
| OYE | Flow cytometric reagents and accessories. |
| PER | Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-31 |
| Device Publish Date | 2022-08-23 |
On-Brand Devices [BD FACSDuet]
| 00382906631282 | BD FACSDuet Sample Prep US |
| 00382906663405 | BD FACSDuet™ Premium Sample Preparation System |
Trademark Results [BD FACSDuet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD FACSDUET 87385223 not registered Live/Pending |
Becton, Dickinson and Company 2017-03-24 |
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